Synthetic routes to drug products typically introduce several potentially mutagenic impurities (PMIs) which require controlling a safe level in the final substance, generally directed by control options within ICH M7 guideline. These are most commonly introduced due their specific synthetic utility; however, formation of PMI can also occur indirectly from combination otherwise nonmutagenic sour...

INTRODUCTION: Niclosamide is in the antihelminthic family especially effective against cestodes that infect humans. It is also used as a pesticide. , Niclosamide is used specifically to treat tapeworms and is not effective against other worms such as pinworms or roundworms. IUPAC name for Niclosamide is 5-chloro-N-(2chloro-4-nitrophenyl)-2-hydroxybenzamide, molecular weight is 327.119 g/mol, an...

Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, differe...

Piracetam was subjected to the hydrolytic, oxidative, thermal and photolytic stress, according to ICH guideline Q1A (R2). The drug depicted degradation only in basic conditions, while it was stable to other stress conditions (acidic, neutral hydrolysis, thermal and photolytic conditions). A total of one degradation product was formed, which were separated on a BEH column employing an isocratic ...

Article history: Received on: 29/02/2016 Revised on: 15/03/2016 Accepted on: 06/04/2016 Available online: 28/05/2016 A simple HPLC method for determination of Benzalkonium chloride in various ophthalmic solutions was developed. The chromatographic analysis was achieved using CN column (250 mm, 4.6 mm i.d., 5 μm) with isocratic mobile phase consisting of acetonitrile phosphate buffer (pH 5.5; 0....

Stability-indicating High Performance Liquid Chromatographic (HPLC) method was developed for simultaneous Aspirin and Clopidogrel, A Phenomenex Gemini C-18, 5 μm column having 250mm x 4.6 mm i.d. in isocratic mode, with mobile phase containing buffer solution 0.3% orthophosphoric acid : acetonitrile (65: 35, v/v). The flow rate was 1 ml/min and effluents were monitored at 266 nm. For linearity ...

BACKGROUND AND PURPOSE Conflicting reports in the literature exist with regard to the association of apolipoprotein E (apo E) alleles and lobar intracerebral hemorrhage (ICH). We genotyped 12 single-nucleotide polymorphisms in the 5' upstream regulatory, exonic, and intronic regions of the apo E gene and performed genotype and haplotype association analyses. METHODS We prospectively enrolled ...

OBJECTIVE To test the hypothesis that the effect of antithrombotic medications on the risk of intracerebral hemorrhage (ICH) varies according to the location of the hematoma. METHODS Consecutive patients with ICH were enrolled as part of the Multicenter Study on Cerebral Hemorrhage in Italy (MUCH-Italy). Multivariable logistic regression models served to examine whether risk factors for ICH a...

BACKGROUND The risk of ischemic stroke/thromboembolic events after an intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) who are on warfarin treatment is poorly characterized. The aim of this study was to assess the association between the risk of ischemic stroke/thromboembolic events and ICH. METHODS Linkage of three Danish nationwide administrative registries in the per...